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EVEREST Spinal System

by K2m, Incorporated 510(k)

Active United States

510(k) K161369

Overview

The EVEREST Spinal System is a spinal implant system designed for use in orthopedic spinal procedures. It features a top-loading pedicle screw system that accommodates titanium and cobalt chrome rods of two different diameters. The system includes instrumentation intended to assist in spinal correction maneuvers.

The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is indicated for use in spinal fusion procedures to treat degenerative and deformity pathologies. The system received FDA 510(k) clearance (K161369) as substantially equivalent to a predicate device.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK161369 Date21 Jul 2016ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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